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| CLINICAL DEVELOPMENT PIPELINE | |
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HGS has a well balanced and deep portfolio of novel drugs directed toward diseases that represent significant unmet medical need. BENLYSTA® (belimumab) has successfully completed Phase 3 development in systemic lupus erythematosus. We and GlaxoSmithKline submitted marketing applications for BENLYSTA in the United States and Europe in June 2010. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010. In June 2010, we received preliminary written feedback from the FDA regarding our BLA seeking approval in the United States to market 900-mcg ZALBIN™ dosed every two weeks for the treatment of chronic hepatitis C. FDA expressed concerns regarding the risk-benefit assessment of ZALBIN administered in this dosing regimen. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency. HGS and Novartis are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen. In May 2009, we submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax. We received a Complete Response Letter in November 2009 and continue to work closely with the FDA to obtain approval for raxibacumab. Right behind these late-stage products is an emerging high-potential mid-stage pipeline, led by our oncology program and including possible new indications for BENLYSTA. We also have substantial financial rights to a number of products in the GSK clinical pipeline. GSK is currently conducting Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease and Syncria® (albiglutide) in patients with type 2 diabetes mellitus.
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